Replagal

RSS

agalsidase alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Replagal. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Replagal.

This EPAR was last updated on 13/05/2022

Authorisation details

Product details
Name
Replagal
Agency product number
EMEA/H/C/000369
Active substance
agalsidase alfa
International non-proprietary name (INN) or common name
agalsidase alfa
Therapeutic area (MeSH)
Fabry Disease
Anatomical therapeutic chemical (ATC) code
A16AB03
Publication details
Marketing-authorisation holder
Takeda Pharmaceuticals International AG Ireland Branch
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
03/08/2001
Contact address

Block 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 Y754
Ireland

Product information

12/05/2022 Replagal - EMEA/H/C/000369 - IAIN/0120/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).

Assessment history

How useful was this page?

Add your rating
Average
2 ratings
1 rating
1 rating